Surgical stapler cartridge loading and unloading

ABSTRACT

An exemplary surgical method includes possessing a loader that holds a curved-tip cartridge, and a surgical stapler that includes an anvil and channel at a distal end thereof; causing at least one of the loader and the channel to move toward the other; as a result of the causing, engaging the loader and the curved-tip cartridge with the channel; and causing at least one of the loader and the channel to move away from the other, such that the curved-tip cartridge remains engaged with the channel. That method further may include actuating the surgical stapler; grasping the unloader; sliding the unloader toward the channel; disengaging the curved-tip cartridge from the channel with the unloader; and withdrawing the unloader away from said channel, wherein the withdrawing causes the curved-tip cartridge to disengage from the channel.

CROSS REFERENCE TO RELATED APPLICATION(S)

This application is a divisional of, and claims priority under 35 U.S.C.§ 120 to, U.S. application Ser. No. 15/646,524, filed Jul. 11, 2017, thecontent of which is incorporated by reference herein in its entirety.

FIELD OF THE INVENTION

The invention generally relates to surgical staplers and stapling.

BACKGROUND

A surgical stapler both staples and cuts tissue to transect that tissuewhile leaving the cut ends hemostatic. A typical surgical staplerreceives at its distal end a disposable single-use cartridge withseveral rows of staples, and includes an anvil opposed to the cartridge.

Conventional surgical staplers have an anvil with a straight or curveddistal end. However, with the exception of surgical stapler cartridgesmanufactured by Dextera Surgical Inc. of Redwood City, Calif., allconventional surgical stapler cartridges on the market today have astraight distal end. Surgeons, nurses, technicians, and/or otherpersonnel in the operating room may be hesitant to load or unloadcurved-tip staple cartridges into a surgical stapler by hand, as theyare largely unfamiliar with such cartridges. Thus, there is a need tosimplify the process of loading and unloading curved-tip staplecartridges such that the user has more confidence in handling thosecurved-tip cartridges.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary loader.

FIG. 2 is a perspective view of the exemplary loader of FIG. 1 with acartridge held thereby.

FIG. 3 is an exploded view of FIG. 2.

FIG. 4 is a perspective view upward into an upper loader body of theloader of FIG. 1.

FIG. 5 is a bottom view of the upper loader body of FIG. 4.

FIG. 6 is a side cross-section view of the exemplary loader with acartridge held thereby of FIG. 2.

FIG. 7 is a perspective view into a lower loader body of the loader ofFIG. 1.

FIG. 8 is a perspective view of the proximal end of the exemplary loaderof FIG. 1 and an exemplary stapler channel in proximity to one another.

FIG. 9 is a perspective view of an exemplary unloader.

FIG. 10 is a top view of the unloader of FIG. 9.

FIG. 11 is a side cross-section view of a curved-tip cartridge engagedwith a channel boss of the stapler channel.

FIG. 12 is a side cross-section view of the unloader of FIG. 9,disengaging a curved-tip cartridge from a stapler channel.

FIG. 13 is a schematic drawing of a magazine including a plurality ofloaders and unloaders.

FIG. 14 is a side view of a combination loader/unloader.

The use of the same reference symbols in different figures indicatessimilar or identical items.

DETAILED DESCRIPTION

Loader

Referring to FIGS. 1-3, a loader 2 is shown. The loader 2 provides anergonomic and simple way to insert a curved-tip cartridge 4 into astapler channel.

As seen in FIG. 3, the loader 2 may be fabricated as a two-piececomponent, with an upper loader body 2 a and a lower loader body 2 b.The two loader components 2 a, 2 b may be attached to one another byadhesive, by fasteners, and/or in any other suitable manner. Thecomponents 2 a, 2 b may be fabricated by injection molding, additivemanufacturing (colloquially referred to as “3-D printing”), by stamping,or by any other suitable process. Alternately, the loader 2 may befabricated as a single component in any suitable manner, such as byadditive manufacturing. The upper loader body 2 a and lower loader body2 b may be referred to collectively as a body.

In some embodiments, the cartridge 4 may hold one or more staple stripswith staples frangibly affixed thereto, as described incommonly-assigned U.S. Pat. No. 7,988,026, which is hereby incorporatedby reference in its entirely. In such embodiments, the staples may beconfigured for direct contact with a wedge, and the cartridge 4 does notinclude conventional staple drivers, as described in commonly-assignedU.S. Pat. No. 7,988,026. Alternately, in other embodiments, thecartridge 4 holds conventional U-shaped surgical staples andconventional staple drivers, arranged such that motion of a wedgerelative to a staple driver causes the staple driver to contact acorresponding staple and urge that staple toward an anvil. The cartridge4 may include any suitable number of rows of staples, corresponding torows of staple openings 6 on the upper surface 8 of the cartridge 4. Asshown in FIG. 2, as one example the cartridge 4 includes four rows ofstaple openings 6, the rows extending longitudinally and substantiallyparallel to one another, with two rows on each side of the longitudinalcenterline of the cartridge 4. In other embodiments, the cartridge 4 mayinclude any other number of rows of staple openings 6, arrangedsymmetrically or asymmetrically. For example, the cartridge 4 mayinclude six rows of staple openings 6, with three rows on each side ofthe longitudinal centerline of the cartridge 4, as in a conventionalsurgical staple cartridge. The upper surface 8 of the cartridge 4 mayhave any suitable shape or orientation, and may include two or moreplanar surfaces angled relative to one another. Alternately, the uppersurface 8 of the cartridge 4 may be a single substantially planarsurface. The cartridge 4 may be configured as described incommonly-assigned U.S. Pat. No. 9,004,339, which is hereby incorporatedby reference in its entirety.

The cartridge 4 includes a curved tip 10. The curved tip 10 is curvedupward relative to the longitudinal centerline of the cartridge 4 suchthat the curved tip 10 terminates at a location above the upper surface8 of the cartridge 4. The curved tip 10 may taper in width and/orthickness toward the distal direction from the junction between thecurved tip 10 and the remainder of the cartridge 4. As used herein, theterm “curved-tip cartridge” is defined to mean a surgical staplecartridge 4 with a curved tip at its distal end.

The cartridge 4 also may include a trough 12 defined through the uppersurface 8. In some embodiments, the trough 12 extends distally from theproximal end of the cartridge 4, such that the proximal end of thecartridge 4 is open at its intersection the proximal end of the trough12. Alternately, the trough 12 does not intersect the proximal end ofthe cartridge 4. The trough 12 may have any suitable length along theupper surface 8, and may extend along part or all of that upper surface8. The trough 12 may have any suitable depth. The upper loader body 2 aand lower loader body 2 b collectively define a cavity 14 therein inwhich the cartridge 4 may be held.

Referring also to FIGS. 4-5, an inner surface 16 of the upper loaderbody 2 a defines part of the cavity 14 described above. A proximal upperspring 18 is defined in the upper loader body 2 a. Slots 20 may extendlaterally along the lateral sides of the proximal upper spring 18,separating the lateral sides of the proximal upper spring 18 from aremainder of the upper loader body 2 a. The distal end 22 of theproximal upper spring 18 may be connected to a remainder of the upperloader body 2 a in any suitable manner. In one embodiment, the proximalupper spring 18 has the same thickness as the adjacent portion of theupper loader body 2 a and extends proximally from the junction betweenthe distal end 22 of the proximal upper spring 18 and the remainder ofthe upper loader body 2 a. In other embodiments, the proximal upperspring 18 may be connected to a remainder of the upper loader body 2 aby a living hinge, which is a segment of material having lesserthickness that concentrates bending in that segment. Such a living hingemay be located at the junction between the proximal upper spring 18 andthe remainder of the upper loader body 2 a.

The upper surface of the proximal upper spring 18 may have any suitableshape. Referring to FIG. 4, at least a portion of the lower surface 24of the proximal upper spring 18 may be angled downward proximally fromthe junction between the distal end 22 of the proximal upper spring 18and the remainder of the upper loader body 2 a. At least a portion ofthe lower surface 24 may be substantially planar. In other embodiments,at least a portion of the lower surface 24 of the proximal upper spring18 may be curved, or otherwise shaped, downward proximally from thejunction between the distal end 22 of the proximal upper spring 18 andthe remainder of the upper loader body 2 a. The proximal upper spring 18may include a proximal fin 26 at its proximal end. The proximal fin 26includes the lowest point on the proximal upper spring 18. Viewed fromthe side, the bottom 28 of the proximal fin 16 may be generallyV-shaped, or may be shaped in any other suitable manner that facilitatesengagement between the proximal fin 16 and the cartridge 4.

The proximal upper spring 18 may be tapered laterally in the proximaland/or downward directions; for example, as shown in FIG. 4. Theproximal upper spring 18 may have any suitable cross-sectionperpendicular to the longitudinal axis of the loader 2 that allows it toengage the trough 12 and/or other portion of the cartridge 4effectively. For example, where the trough 12 is substantially V-shapedand/or tapered in the downward direction, the cross-sectionperpendicular to the longitudinal axis of the loader 2 of the proximalupper spring 18 similarly may be substantially V-shaped and/or taperedin the downward direction.

As shown in FIGS. 1-5, the proximal upper spring 18 is in a neutralposition. In the neutral position, the proximal upper spring 18 and/orits junction with the remainder of the upper loader body 2 a does notstore potential energy resulting from flexure of the proximal upperspring 18. The proximal upper spring 18 may be fabricated at the sametime as the remainder of the upper loader body 2 a, may be fabricated bycutting the slots 20 in the upper loader body 2 a after fabrication ofthat component, or in any other suitable manner.

Referring also to FIG. 6, the distal end of the inner surface 16 of theupper loader body 2 a is shaped to assist in holding the cartridge 4 inplace in the loader 2. In the inner surface 16, a retainer ramp 30extends upward in the distal direction. The retainer ramp 30 may besubstantially flat, as seen in FIG. 6, or may be curved or shaped in anyother suitable manner. As described in greater detail below, initiallythe distal end of the curved tip 10 is positioned distal to and incontact with the retainer ramp 30. Distal to the retainer ramp 30, theinner surface 16 curves substantially at a peak 32 to match thecurvature of the distal end of the curved tip 10. In other embodiments,the inner surface 16 is shaped in any other suitable manner thataccommodates the distal end of the curved tip 10. Distal to the peak 32,a seating ramp 34 extends downward in the distal direction. The seatingramp 34 may be substantially flat, as seen in FIG. 6, or may be curvedor shaped in any other suitable manner. The seating ramp 34 may beangled downward at substantially a 30 degree angle to a horizontalplane, or may be angled or oriented in any other suitable manner. At thedistal end of the seating ramp 34, optionally a wall 36 may extenddownward substantially vertically. The retainer ramp 30, peak 32, and/orseating ramp 34 may have any suitable width; one or more may be as wideas the distal end of the curved tip 10, narrower than the distal end ofthe curved tip 10, or wider than the distal end of the curved tip 10.

Referring also to FIG. 7, an inner surface 40 of the lower loader body 2b defines part of the cavity 14 described above. Referring also to FIG.8, a tongue 42 extends proximally from a remainder of the lower loaderbody 2 b. Slots 44 may extend laterally along the lateral sides of thetongue 42, separating the lateral sides of the tongue 42 from aremainder of the lower loader body 2 b. The distal end 46 of the tongue42 may be connected to a remainder of the lower loader body 2 b in anysuitable manner. In one embodiment, the distal end 46 of the tongue 42has the same thickness as the adjacent portion of the lower loader body2 b. In other embodiments, the tongue 42 may be connected to a remainderof the lower loader body 2 b by a living hinge, which is a segment ofmaterial having lesser thickness that concentrates bending in thatsegment. Such a living hinge may be located at the junction between thetongue 42 and the remainder of the lower loader body 2 b. The uppersurface 48 of the tongue 42 may be substantially flat, or may have anyother suitable shape. The lower surface of the tongue 42 may have anysuitable shape. As seen in FIG. 6, the tongue 42 may have asubstantially constant thickness along its longitudinal dimension.Alternately, in other embodiments the tongue 42 may vary in thicknessalong at least part of its length.

Referring to FIG. 8, a stapler channel 50 is shown. The stapler channel50 is the portion of the end effector of a surgical stapler that isconfigured to receive the cartridge 4. The stapler channel 50 and thebottom of the cartridge 4 may have any suitable shapes as long as theyare able to mate and the stapler channel 50 is able to hold thecartridge securely. For example, as shown in FIG. 8, the inner surfacestapler channel 50 forms a generalized “W” shape. A channel boss 52extends from the distal end of the stapler channel 50. Advantageously,the channel boss 52 extends from the bottom of the stapler channel 50.In one embodiment, the channel boss 52 includes a generally squarechannel boss opening 56 defined therethrough. In other embodiments, thechannel boss opening need not extend all the way through the channelboss 52. In other embodiments, the channel boss opening 56 may have anyother suitable shape, such as but not limited to rectangular, circularor oval. The channel boss opening 56 has a size and shape suitable toengage a cartridge bump, as described in greater detail below.

Returning to the loader 2 and referring also to FIGS. 1, 3 and 6-8, aramp 60 extends upward in the distal direction from the distal end ofthe tongue 42. The ramp 60 is sized and shaped to engage the channelboss 52 upon loading, as described in greater detail below. In oneembodiment, the ramp 60 is substantially as wide as the channel boss 52.Optionally, on the inner surface 40 of the lower loader body 2 b, twokeying walls 62 may be provided, each spaced apart from the tongue 42 bya corresponding slot 44. The keying walls 62 engage the sides 64 of thechannel boss 52 to ensure proper orientation of the stapler channel 50relative to the loader 2 and cartridge 4 during loading, as described ingreater detail below. To both sides of the ramp 60, walls 68 are definedon the inner surface 40 of the lower loader body 2 b, where the walls 68have a shape and size corresponding to the outer shape and size of thestapler channel 50.

Referring also to FIGS. 3, 6 and 7, a proximal bottom spring 70 extendsproximally from a remainder of the lower loader body 2 b. Slots 72 mayextend laterally along the lateral sides of the proximal bottom spring70, separating the lateral sides of the proximal bottom spring 70 from aremainder of the lower loader body 2 b. The distal end 74 of theproximal bottom spring 70 may be connected to a remainder of the lowerloader body 2 b in any suitable manner. In one embodiment, the proximalbottom spring 70 has the same thickness as the adjacent portion of thelower loader body 2 b and extends proximally from the junction betweenthe distal end 74 of the proximal bottom spring 70 and the remainder ofthe lower loader body 2 b. In other embodiments, the proximal bottomspring 70 may be connected to a remainder of the lower loader body 2 bby a living hinge, which is a segment of material having lesserthickness that concentrates bending in that segment. Such a living hingemay be located at the junction between the proximal bottom spring 70 andthe remainder of the lower loader body 2 b.

The lower surface of the proximal bottom spring 70 may have any suitableshape. Referring to FIG. 6, at least a portion of the upper surface 76of the proximal bottom spring 70 may be substantially planar from thejunction between the distal end 74 of the proximal bottom spring 70 andthe remainder of the lower loader body 2 b. That planar portion of theupper surface 76 may be substantially parallel to the longitudinalcenterline of the loader 2. In other embodiments, at least a portion ofthe upper surface 76 of the proximal bottom spring 70 may be curved, orotherwise shaped, proximally from the junction between the distal end 74of the proximal bottom spring 70 and the remainder of the lower loaderbody 2 b.

The proximal bottom spring 70 may include a tab 78 at its proximal end.The tab 78 may include a distal surface 80 that is substantiallyperpendicular to the planar upper surface 76 of the proximal bottomspring 70. The distal surface 80 may be substantially planar. In otherembodiments, the distal surface 80 may be oriented and/or shaped in anyother suitable manner. The tab 78 may include an upper tab surface 82that is angled downward in the proximal direction from its junction withthe distal surface 80. The upper tab surface 82 may be substantiallyplanar. In other embodiments, the upper tab surface 82 may be curved ormay be shaped in any other suitable manner. At its proximal end, theupper tab surface 82 intersects a proximal surface 84 of the tab 78. Theintersection between the upper tab surface 82 and proximal surface maybe curved, or may be an angle or any other suitable shape. The proximalsurface 84 may be substantially planar. In other embodiments, theproximal surface 84 may be curved or may be shaped in any other suitablemanner.

As shown in FIGS. 1-6, the proximal bottom spring 70 is in a neutralposition. In the neutral position, the proximal bottom spring 70 and/orits junction with the remainder of the lower loader body 2 b does notstore potential energy resulting from flexure of the proximal bottomspring 70. The proximal bottom spring 70 may be fabricated at the sametime as the remainder of the lower loader body 2 b, may be fabricated bycutting the slots 20 in the lower loader body 2 b after fabrication ofthat component, or in any other suitable manner. The proximal bottomspring 70 and proximal upper spring 18 each may be in the neutralposition prior to loading. When the loader 2 holds a cartridge 4, theshapes of the proximal bottom spring 70 and proximal upper spring 18interact with the cartridge 4 to maintain a gap between the cartridge 4and the inner surface 40 of the lower loader body 2 b. Thus, when theloader 2 holds a cartridge 4, at least one of the proximal bottom spring70 and proximal upper spring 18 may be deflected away from a neutralposition, such that at least one of the proximal bottom spring 70 andproximal upper spring 18 is biased against the cartridge 4 to hold thecartridge 4 securely in place.

The upper tab surface 82 of the proximal bottom spring 70 contacts aportion of the cartridge 4. As seen in FIG. 6, the upper tab surface 82contacts the cartridge 4 at a location distal to the point of contactbetween the proximal upper spring 18 and the cartridge 4. The proximalbottom spring 70 exerts more force upward on the cartridge 4 than theproximal upper spring 18 exerts downward on the cartridge 4 duringinsertion, as described in greater detail below. In this way, as in theneutral position, the proximal bottom spring 70 and proximal upperspring 18 advantageously interact to maintain a gap between thecartridge 4 and the inner surface 40 of the lower loader body 2 b.

Referring also to FIGS. 3, 6 and 7, a distal bottom spring 90 extendsdistally from a remainder of the lower loader body 2 b. Slots 92 mayextend laterally along the lateral sides of the distal bottom spring 90,separating the lateral sides of the distal bottom spring 90 from aremainder of the lower loader body 2 b. The proximal end 94 of thedistal bottom spring 90 may be connected to a remainder of the lowerloader body 2 b in any suitable manner. In one embodiment, the distalbottom spring 90 has the same thickness as the adjacent portion of thelower loader body 2 b and extends distally from the junction between theproximal end 94 of the distal bottom spring 90 and the remainder of thelower loader body 2 b. In other embodiments, the distal bottom spring 90may be connected to a remainder of the lower loader body 2 b by a livinghinge, which is a segment of material having lesser thickness thatconcentrates bending in that segment. Such a living hinge may be locatedat the junction between the distal bottom spring 90 and the remainder ofthe lower loader body 2 b.

The lower surface of the distal bottom spring 90 may have any suitableshape. Referring to FIG. 6, at least a portion of the upper surface 96of the distal bottom spring 90 may be substantially planar from thejunction between the proximal end 94 of the distal bottom spring 90 andthe remainder of the lower loader body 2 b. That planar portion of theupper surface 96 may be substantially parallel to the longitudinalcenterline of the loader 2. In other embodiments, at least a portion ofthe upper surface 96 of the distal bottom spring 90 may be curved, orotherwise shaped, distally from the junction between the proximal end 94of the distal bottom spring 90 and the remainder of the lower loaderbody 2 b.

The distal bottom spring 90 may include a finger 98 at its distal end.The finger 98 extends upward from a remainder of the distal bottomspring 90, and may form an angle with the remainder of the distal bottomspring 90. The finger 98 may be angled distally relative to a remainderof the distal bottom spring 90, as seen in FIG. 6. The tip 100 of thefinger 98 may be curved, rounded or otherwise smooth. In otherembodiments, the tip 100 of the finger 98 may be angled or flat. The tip100 of the finger 98 initially engages a portion of the curved tip 10 ofthe cartridge 4, as described in greater detail below. As shown in FIGS.1-6, the distal bottom spring 90 is in a neutral position. In theneutral position, the distal bottom spring 90 and/or its junction withthe remainder of the lower loader body 2 b does not store potentialenergy resulting from flexure of the distal bottom spring 90. The distalbottom spring 90 may be fabricated at the same time as the remainder ofthe lower loader body 2 b, may be fabricated by cutting the slots 92 inthe lower loader body 2 b after fabrication of that component, or in anyother suitable manner. In the neutral position, the tip 100 of thefinger 98 is not biased against the curved tip 10 of the cartridge 4,but rather rests against the curved tip 10 of the cartridge 4 to assistin holding the cartridge 4 in place. In other embodiments, when theloader 2 holds a cartridge 4, the distal bottom spring 90 may bedeflected away from a neutral position, such that distal bottom spring90 is biased against the cartridge 4 to hold the cartridge 4 securely inplace.

The outer surface 110 may include one or more grooves 112 definedtherein, in order to facilitate grasping of the loader 2 between fingersof a user. In other embodiments, the grooves 112 may be omitted. Thesurface finish of the loader 2 advantageously facilitates the ability ofa user to grasp and hold the loader 2. In other embodiments, the usergrasps the loader 2 with a forceps or other instrument in use, such thatthe surface finish of the loader 2 is not as important to its function.

Unloader

Referring to FIGS. 9-11, an unloader 120 is shown. The unloader 120provides an ergonomic and simple way to remove a curved-tip cartridge 4from a stapler channel 50. The unloader 120 may be fabricated as aone-piece component, such as by injection molding, additivemanufacturing (colloquially referred to as “3-D printing”), by stamping,or by any other suitable process. Alternately, two or more componentsmay be fabricated separated and then later assembled in any suitablemanner to form the unloader 120.

The unloader 120 may include an aperture 122 defined through itsproximal end. The aperture 122 extends through a proximal body 124 ofthe unloader 120. The interior of the unloader 120 may be a cavity 126.The upper surface 128 of the unloader 120 may include an opening 130defined therethrough. The upper surface 128 of the unloader 120 may begenerally planar. Alternately, the upper surface 128 of the unloader 120may have any other suitable shape. The size and shape of the opening 130is defined by the intersection between the cavity 126 and the uppersurface 128 of the unloader 120. In some embodiments, the opening 130may be substantially rectangular. In another embodiments, the opening130 may have any other shape and/or symmetry, or may be asymmetrical inconfiguration.

The shape of at least part of the perimeter of the aperture 122 and/orof a lower surface 132 of the cavity 126 may correspond to the shape andsize of the stapler channel 50. As described in greater detail below, aspart of the unloading process the stapler channel 50 may be slid throughand held by the aperture 122, such that the shapes of the aperture 122and stapler channel 50 are related. In one embodiment, the aperture 122includes a horizontal plane 134 on each lateral side, such that thehorizontal planes 134 are spaced laterally apart from one another onopposite sides of the perimeter of the aperture 122. Referring also toFIG. 8, each horizontal plane 134 is configured to engage acorresponding upper edge 138 of the stapler channel 50. This engagementassists in holding the stapler channel 50 securely relative to theunloader 120 during the unloading process, and also provides a keyingelement to ensure the stapler channel 50 is inserted correctly into theunloader 120. The bottom edge of the aperture 122 may be defined by thelower surface 132 of the cavity 126 of the unloader 120. The lowersurface 132 of the cavity 126 may be curved in a generally concavemanner. The size and shape of the lower surface 132 and the horizontalplanes 134 may be toleranced relative to the stapler channel 50 to bothallow the stapler channel 50 to slide through the aperture 122, and tohold the stapler channel 50 in a desired position relative to theunloader 120.

Referring to FIGS. 9-10, two side ramps 140 are spaced distally from theaperture 122 and are spaced laterally apart from one another. Each sideramp 140 extends upward in the distal direction from the lower surface132 of the cavity 126. Longitudinally between the side ramps 140 and theaperture 122, the curvature of the lower surface 132 is substantiallyconstant. The side ramps 140 are laterally spaced from one another adistance substantially equal to the width of the channel boss 52. Thespace between the side ramps 140 may be referred to as the trough 142.At the distal end of the trough 142 is a stop 144, which is configuredto contact the end of the channel boss 52 and thereby stop longitudinalrelative motion between the stapler channel 50 and the unloader 120. Thestop 144 provides a hard stop to enhance control and to enhance controland to provide feedback to the user that the stapler channel 50 hasmoved sufficiently far to unload the cartridge 4. The stop 144 may be avertical wall extending upward from the lower surface 132 of the cavity126. In some embodiments, the stop 144 is substantially as tall as thechannel boss 52. In other embodiments, the stop 144 may be taller orshorter than the channel boss 52.

A center ramp 146 extends upward in the distal direction from the top ofthe stop 144. The center ramp 146 may be substantially planar. In otherembodiments, the center ramp 146 may be curved, or may be shaped in anyother suitable manner. As described in greater detail below, the centerramp 146 is configured to engage the curved tip cartridge 4 as theunloader 120 and stapler channel 50 move relatively toward one another.

The outer surface 150 may include one or more grooves 152 definedtherein, in order to facilitate grasping of the unloader 120 betweenfingers of a user. In other embodiments, the grooves 152 may be omitted.The surface finish of the unloader 120 advantageously facilitates theability of a user to grasp and hold the unloader 120. In otherembodiments, the user grasps the unloader 120 with a forceps or otherinstrument in use, such that the surface finish of the unloader 120 isnot as important to its function.

Operation—Loader

For the purpose of this description, initially, a fresh, unusedcartridge 4 is held by the loader 2, and the stapler channel 50 is emptyand does not hold a cartridge.

The user grasps the loader 2 that holds a fresh cartridge 4, with his orher fingers, forceps, grasper, robotic end effector, or other tool. Theuser may be a physician or may be a person who is performing tests onthe loader 2 and/or cartridge 4, such as quality control testing duringmanufacturing. As used in this document, the term “possessing” theloader 2 means affirmatively holding the loader 2 directly with a handor indirectly via an intervening tool or tools.

Initially, referring also to FIGS. 4 and 6, the loader 2 holds thecartridge 4 securely. The proximal bottom spring 70 exerts an upwardforce on the cartridge 4, such as via contact between the tab 78 of theproximal bottom spring 70 and the bottom of the cartridge 4. Thepresence of the cartridge 4 in the loader 2 deflects the proximal bottomspring 70 downward, such that the proximal bottom spring 70 storesenergy and is biased upward against the cartridge 4. The proximal upperspring 18 exerts a downward force on the cartridge 4, such as viacontact between the proximal fin 26 of the proximal upper spring 18 andthe top of the cartridge 4. According to some embodiments, the forceexerted upward by the proximal bottom spring 70 on the cartridge 4 isgreater than the force exerted downward by the proximal upper spring 18on the cartridge. Further, according to some embodiments, the locationof contact between the proximal bottom spring 70 and the cartridge 4 isdistal to the location of contact between the proximal upper spring 18and the cartridge 4. As a result, the proximal upper spring 18 andproximal bottom spring 70 maintain a gap between the cartridge 4 and theinner surface 40 of the lower loader body 2 b. Further, the engagementbetween the proximal upper spring 18, proximal bottom spring 70, and thecartridge 4 assists in orienting the distal end of the cartridge 4upward, due to the difference in longitudinal location of contact withthe cartridge 4 of the proximal upper spring 18 and the proximal bottomspring 70. Initially, in some embodiments, prior to loading, the distalend of the curved tip 10 rests against the peak 32 in the inner surface16 of the upper loader body 2 a. Further, the tip 100 of the finger 98of the distal bottom spring 90 may be biased upward against the curvedtip 10.

Next, the user causes at least one of the loader 2 and the staplerchannel 50 to move toward the other, in any suitable manner. As a resultof that moving, the stapler channel 50 engages the loader 2. In oneembodiment, referring also to FIGS. 6-8, the distal end of the staplerchannel 50 engages the tongue 42, deflecting the tongue 42 downward. Asdescribed above, the stapler channel 50 optionally includes a channelboss 52 at a distal end thereof. The channel boss 52 slides between thetwo keying walls 62 defined in the inner surface 40 of the lower loaderbody 2 b. Engagement between the keying walls 62 and the lateral sides64 of the channel boss 52 provides rotational alignment between thecartridge 4 and the stapler channel 50, which allows the stapler channel50 to receive the cartridge 4 properly. Alternately, one or more otherkeying features may be provided to align the loader 2 and staplerchannel 50 relative to one another, whether or not the stapler channel50 includes a channel boss 52. As the stapler channel 50 itself entersthe loader 2, the stapler channel 50 is received by the walls 68 definedon the inner surface 40 of the lower loader body 2 b, which correspondto the shape of the stapler channel 50, and which may be dimensioned tobe slightly larger than the corresponding dimensions of the staplerchannel 50. The walls 68 act as secondary keying fixtures to hold thestapler channel 50 in a desired rotational alignment.

As the loader 2 and stapler channel 50 continue to slide together, thechannel boss 52 slides up the ramp 60 defined in the inner surface 40 ofthe lower loader body 2 b. As sliding continues, the channel boss 52slides off the distal end of the ramp 60 and into engagement with theupper tab surface 82 of the tab 78. The upper tab surface 82 is angleddownward in the proximal direction, and the proximal end of the uppertab surface 82 may be in proximity to the ramp 60. Thus, as the channelboss 52 slides distal to the distal end of the ramp 60, it slides alongthe upper tab surface 82 of the tab 78. As the channel boss 52, followedby a remainder of the stapler channel 50, slides against the upper tabsurface 82, the channel boss 52 and then the stapler channel 50 urge thetab 78 downward.

Motion of the tab 78 downward by its contact with the channel boss 52and then the stapler channel 50 causes the tab 78, and the proximalbottom spring 70, to move out of engagement with the cartridge 4. Asdescribed above, the proximal bottom spring 70 initially exerts a forceupward on the cartridge 4 that is greater than the force exerteddownward by the proximal upper spring 18 on the cartridge. Bydisengaging the proximal bottom spring 70 from the cartridge 4, thechannel boss 52 and then the stapler channel 50 remove from thecartridge 4 the upward force applied to the cartridge 4 by the proximalbottom spring 70. As a result, the downward force applied to thecartridge 4 by the proximal upper spring 18 is counteracted no longer bythe proximal bottom spring 70, and the proximal upper spring 18 pushesthe cartridge 4 downward into the stapler channel 50 such as via contactbetween the proximal fin 26 of the proximal upper spring 18 and the topof the cartridge 4. At the same time, due to the contact between theramp 60 and stapler channel 50 that urges the stapler channel 50 upwardrelative to the proximal upper spring 70, the stapler channel 50 ispushed upward relative to the cartridge 4.

The cartridge 4 begins to seat in the stapler channel 50. Due to contactbetween the tip 100 of the finger 98 of the distal bottom spring 90 andthe distal end of the cartridge 4, the distal end of the cartridge 4remains higher than the proximal end of the cartridge 4. Such anorientation of the cartridge 4 allows the proximal end of the cartridge4 to seat first in the stapler channel 50, before the distal end of thecartridge 4. In some embodiments, it may be advantageous to seat theproximal end of the cartridge 4 in the stapler channel 50 before aremainder of the cartridge 4, due to locking mechanisms or otherstructural or mechanical interconnections that may be made between theproximal end of the cartridge 4 and one or more elements of orassociated with the stapler channel 50. Alternately, the proximal end ofthe cartridge 4 need not be seated first in the stapler channel 50, ifdesired.

As the loader 2 and stapler channel 50 continue to slide together, andthe cartridge 4 begins to seat in the stapler channel 50, the linearcomponent of relative motion between the loader 2 and the staplerchannel 50 pushes the cartridge 4 distally in the loader 2. Referringalso to FIG. 6, and as described above, initially the distal end of thecurved tip 10 of the cartridge 4 resides against or in proximity to thepeak 32 defined in the inner surface 16 of the upper loader body 2 a. Asthe cartridge 4 is pushed distally in the loader 2, the distal end ofthe curved tip 10 of the cartridge 4 is pushed distally away from thepeak 32 and onto the seating ramp 34 defined in the inner surface 16 ofthe upper loader body 2 a distal to the peak 32. As described above, theseating ramp 34 extends downward in the distal direction from the peak32. As the cartridge 4 is pushed distally in the loader 2, the distalend of the curved tip 10 of the cartridge 4 rides along the seating ramp34. The interaction between the distal end of the curved tip 10 of thecartridge 4 and the seating ramp 34 urges the distal end of thecartridge 4 downward. This downward motion of the distal end of thecurved tip 10 of the cartridge 4 pushes the finger 98 of the distalbottom spring 90 downward; the upward force exerted by the distal bottomspring 90 of the cartridge 4 is designed to be less than the downwardforce exerted by the downward motion of the distal end of the curved tip10 of the cartridge 4.

Distal motion of the cartridge 4 ceases when the distal end of thecurved tip 10 of the cartridge 4 encounters the wall 36 defined in theinner surface 16 of the upper loader body 2 a. At or prior to theencounter between the distal end of the curved tip 10 of the cartridge 4and the wall 36, the cartridge 4 seats completely in the stapler channel50. Advantageously, this seating affirmatively connects the cartridge 4to the stapler channel 50. In one embodiment, referring also to FIG. 11,a cartridge bump 58 engages the channel boss opening 56 of the channelboss 52 of the stapler channel 50, such as via a pressure fit.Optionally, this engagement may be confirmed audibly. For example, thecartridge bump 58 snaps into the channel boss opening 56, providing anaudible snap that the user can hear, and audibly confirming theaffirmative connection between the cartridge 4 and the stapler channel50. To be clear, FIG. 11 shows the cartridge 4 and stapler channel 50inside the unloader 120; however, the engagement between the cartridgebump 58 and the channel boss opening 56 as shown in FIG. 11 is the sameas the engagement between the cartridge bump 58 and the channel bossopening 56 that results from the operation of the loader 2 described inthis paragraph.

The cartridge 4 is now engaged with the stapler channel 50. The userthen causes at least one of the loader 2 and the stapler channel 50 tomove away from the other, in any suitable manner. The user continues tograsp the loader 2 that holds a fresh cartridge 4, with his or herfingers, forceps, grasper, robotic end effector, or other tool. Becausethe cartridge 4 is engaged with the stapler channel 50, the componentsof the loader 2 no longer affect the position of the cartridge 4relative to the stapler channel 50. As the cartridge 4 and staplerchannel 50 are withdrawn from the loader 2, the cartridge 4 and staplerchannel 50 move proximal to the finger 98 of the distal bottom spring90, which then moves upward toward its neutral position. The curved tip10 of the cartridge 4 contacts the underside of the proximal upperspring 18 as the cartridge 4 continues to move proximally within theloader 2. The contact between the curved tip 10 of the cartridge 4 andthe underside of the proximal upper spring 18 urges the proximal upperspring upward, out of the way of the cartridge 4 as it is withdrawn fromthe loader 2. As the curved tip 10 of the cartridge 4 moves proximal tothe proximal upper spring 18, the cartridge 4 and stapler channel 50 arefree from the loader 2, and the proximal upper spring 18 moves downwardtoward its neutral position.

The cartridge 4 is now loaded into the stapler channel 50 and ready foruse.

Next, the user positions the cartridge 4 and stapler channel 50 adjacentto tissue to be treated in the patient and clamps or otherwise securesthe cartridge 4 against that tissue. The stapler channel 50 is part of asurgical stapler, which may have any configuration. Actuation of thesurgical stapler may be performed in any suitable manner, such as butnot limited to actuation as described in in commonly-assigned U.S. Pat.No. 7,988,026. Actuation of the surgical stapler causes the cartridge 4to deploy one or more staples into tissue to be treated. In someembodiments, a plurality of staples are deployed into tissue as a resultof direct contact between at least one wedge in the surgical stapler anda plurality of staples, as described in in commonly-assigned U.S. Pat.No. 7,988,026. In some embodiments, a plurality of staples are brokenoff from a carrier during deployment into tissue, as described in incommonly-assigned U.S. Pat. No. 7,988,026. After actuation, if thestapler channel 50 and cartridge 4 have been clamped against tissue,they are unclamped from tissue.

Operation—Unloader

After the stapler has been actuated and a plurality of staples have beendeployed into tissue from the cartridge 4, that cartridge 4 is spent andis not usable for additional firings. If the user wishes to deployadditional staples into tissue, the user first removes the spentcartridge 4 from the stapler channel 50.

Referring also to FIGS. 9-12, the unloader 120 may be used to remove thespent cartridge 4 from the stapler channel 50. To do so, the user causesat least one of the unloader 120 and the combination of the cartridge 4and stapler channel 50 to move toward the other, in any suitable manner.The shape of at least part of the perimeter of the aperture 122 of theunloader 120 may be defined by the shape of the combination of thecartridge 4 seated in the stapler channel 50. The aperture 122advantageously acts as a keying feature, in order to provide rotationalalignment between the combination of the cartridge 4 and the staplerchannel 50 on the one hand and the unloader 120 on the other. In thisway, the unloader 120 controls the rotational alignment of thecombination of the cartridge 4 and the stapler channel 50 on the onehand and the unloader 120 on the other when the combination of thecartridge 4 and the stapler channel 50 is received in the aperture 122.

The aperture 122 also constrains the motion of the stapler channel 50 toa substantially linear motion along or parallel to the longitudinal axisof the unloader 120. The horizontal planes 134 on the lateral sides ofthe aperture 122 advantageously are sized and located to engage an uppersurface or surfaces of the stapler channel 50, lateral to the cartridge4, thereby constraining the motion of the stapler channel 50. Motion ofthe stapler channel 50 in any direction perpendicular to the lineardirection of insertion of the stapler channel 50 into the aperture 122is thus substantially restrained.

As the unloader 2 and the combination of the cartridge 4 and staplerchannel 50 continue to slide together, the stapler boss 52 then slidessubstantially linearly into the trough 142 between the side ramps 140.The side ramps 140 and troughs 142 are spaced apart from the aperture122, such that the stapler boss 52 slides into the trough 142 at a timespaced apart from the time at which the combination of the cartridge 4and stapler channel 50 slides through the distal plane of the aperture122. As the stapler boss 52 slides into the trough 142, referring alsoto FIG. 12, the underside of the distal end 10 of the cartridge 4engages the center ramp 146 at the distal end of and above the trough142.

As the unloader 2 and the combination of the cartridge 4 and staplerchannel 50 continue to slide together, the distal end 10 of thecartridge 4 may engage the side ramps 140. Because the side ramps 140are angled or otherwise oriented upward toward the distal direction,motion of the distal end 10 of the cartridge 4 along the side ramps 140applies a force with an upward component to the distal end 10 of thecartridge 4, and thus urges the distal end 10 of the cartridge 4 upward.As the cartridge 4 and stapler channel 50 move distally relative to theunloader 120, the underside of the distal end 10 of the cartridge 4 thenslides along the center ramp 146. According to other embodiments, thedistal end 10 of the cartridge 4 may engage the center ramp 146 beforeor substantially at the same time as it engages the side ramps 140.Because the center ramp 146 is angled or otherwise oriented upwardtoward the distal direction, motion of the distal end 10 of thecartridge 4 along the center ramp 146 applies a force with an upwardcomponent to the distal end 10 of the cartridge 4, and thus urges thedistal end 10 of the cartridge 4 upward. At the same time, the staplerchannel 50 is restrained against upward motion by the horizontal planes134 of the aperture 122, as described above. Due to engagement betweenthe cartridge 4 and the side ramps 140 and/or the center ramp 146,sufficient force is exerted on the cartridge 4 in the upward directionto separate the cartridge 4 from the stapler channel 50. In oneembodiment, a cartridge bump 58 had been engaged with the channel bossopening 56 of the channel boss 52 of the stapler channel 50 as shown inFIG. 11, such as by a pressure fit, and is disengaged from the channelboss opening 56 upon separation of the cartridge 4 from the staplerchannel 50. Optionally, this disengagement may be confirmed audibly. Forexample, the cartridge bump 58 unsnaps from the channel boss opening 56,providing an audible snap that the user can hear, audibly confirming thedisconnection between the cartridge 4 and the stapler channel 50. Beforeor after disconnection, the distal end of the curved tip 10 of thecartridge 4 may slide through the aperture 130, which is provided toallow unrestricted upward motion of the distal end of the curved tip 10.Contact between the end of the channel boss 52 and the stop 144 stopslongitudinal relative motion between the stapler channel 50 and theunloader 120, to enhance control and to provide feedback to the userthat the stapler channel 50 has moved sufficiently far to unload thecartridge 4.

The user then causes at least one of the unloader 120 and the staplerchannel 50 to move away from the other, in any suitable manner. In someembodiments, the stapler boss 52 slides under the cartridge bump 58,such that the cartridge 4 cannot be reconnected accidentally to thestapler channel 50 during proximal motion of the stapler channel 50relative to the unloader 120. Because the distal end of the cartridge 4has been separated from the stapler channel 50, the proximal motion ofthe stapler channel 50 causes the proximal end of the cartridge 4 toseparate from the stapler channel 50. The spent cartridge 4 thus isdisconnected from the stapler channel 50, and held by the unloader 120.The stapler channel 50 is empty once again.

The user, under most circumstances, unloads a spent cartridge 4 in orderto reload the stapler channel 4 with a fresh, unused cartridge 4. Theuser may repeat the loading process described above, and utilize aloader 2 holding a fresh cartridge 4 to install that cartridge 4 in thestapler channel 50.

According to some embodiments, one or more loaders 2 and/or unloaders120 may be affixed to or fabricated as part of a magazine. Such amagazine may include several loaders 2 and/or unloaders 120, spacedapart from one another and arranged linearly or in any other suitablemanner. The magazine may be placed in the sterile field in proximity tothe patient, or may be located elsewhere in the operating room. Themagazine holds the loaders 2 and/or unloaders 120 securely so that theuser can utilize the loaders 2 and/or unloaders 120 without the need tograsp them; they are held securely as part of the magazine. The magazinemay be clamped to structure near the patient, may be weighted and standalone, or otherwise may be configured to be used as a standalone devicewithout needing to be held by a user during loading and/or unloading.The magazine may be particularly useful in robotic surgery, such asutilizing the da Vinci surgical robot of Intuitive Surgical ofSunnyvale, Calif., where the stapler channel 50 is part of a robotic endeffector or held by a robotic end effector. By placing the loaders 2and/or unloaders 120 in a magazine in proximity to the patient, the user(who typically sits at a control console separate from the patient) canload and/or unload the stapler channel 50 from the control console usingthe robot alone, without additional human intervention to load and/orunload the stapler channel 50.

Referring also to FIG. 14, according to some embodiments, at least oneloader 2 may be connected to at least one unloader 120 to form a unitarystructure. For example, the distal end of a loader 2 may be connected tothe distal end of an unloader 120, as the distal end of each isdescribed above. Such a combination loader/unloader 210 may befabricated as two or more components that are assembled together, or maybe fabricated as a single component such as by injection molding or 3Dprinting. A grasp fixture 220 may be provided on an outer surface of theloader/unloader 210, such as at the junction between the loader 2 andunloader 120. In other embodiments, the grasp fixture 220 may beprovided at any other suitable location on the outer surface of theloader/unloader 210. The grasp fixture 220 may be a post or otherstructure extending outward from the loader/unloader 210. Thecross-section of the grasp fixture 220 may be square, round, triangular,rectangular, or any other suitable shape; the cross-section of the graspfixture 220 may be substantially constant along the grasp fixture 220 ormay vary along the grasp fixture 220.

The grasp fixture 220 may be engaged by a grasper, forceps, robotic endeffector, or other tool. The combination loader/unloader 210 with agrasp fixture 220 may be useful for minimally-invasive surgery,particularly robotic surgery. The combination loader/unloader 210 may beused substantially as described above, with variations as describedhere. The stapler channel 50 is loaded outside the body and insertedinto the body through a first trocar, and the combinationloader/unloader 210 is inserted into the body through a second trocar ata time before, during or after insertion of the stapler channel 50through the first trocar. After deploying staples in tissue, the staplerchannel 50 need not be withdrawn from the first trocar. Instead, thestapler channel 50 may engage the unloader component of the combinationloader/unloader 210 inside the body cavity of the patient. The cartridge4 is unloaded from the stapler channel 50 in the same manner describedabove. The combination loader/unloader 210 then may be rotatedsubstantially 180 degrees about an axis defined by the grasp fixture220, such as by rotating a robotic grasper that engages the graspfixture 220. In this way, the empty stapler channel 50 can remain insubstantially the same place for reloading, simplifying the process. Thestapler channel 50 and loader component of the combinationloader/unloader 210 are then caused to move together relative to oneanother, and a fresh cartridge 4 is loaded into the stapler channel 50in the same manner described above. The combination loader/unloader 210is then removed from the body cavity of the patient through the secondtrocar. Alternately, the combination loader/unloader 210 may be usedoutside the body rather than inside the body, in substantially the samemanner as described with regard to the operation of the loader 2 andunloader 120 separately.

While the invention has been described in detail, it will be apparent toone skilled in the art that various changes and modifications can bemade and equivalents employed, without departing from the presentinvention. It is to be understood that the invention is not limited tothe details of construction, the arrangements of components, and/or themethod set forth in the above description or illustrated in thedrawings. Statements in the abstract of this document, and any summarystatements in this document, are merely exemplary; they are not, andcannot be interpreted as, limiting the scope of the claims. Further, thefigures are merely exemplary and not limiting. Topical headings andsubheadings are for the convenience of the reader only. They should notand cannot be construed to have any substantive significance, meaning orinterpretation, and should not and cannot be deemed to indicate that allof the information relating to any particular topic is to be found underor limited to any particular heading or subheading. Therefore, theinvention is not to be restricted or limited except in accordance withthe following claims and their legal equivalents.

What is claimed is:
 1. An unloader engageable with a stapler channel anda curved-tip cartridge held by the stapler channel, the unloadercomprising: a proximal body; an aperture defined through said proximalbody, said aperture including a perimeter having at least two side wallsfacing each other, the aperture shaped and sized to correspond to anouter surface of the stapler channel and the cartridge held by thestapler channel; a cavity distal to said aperture, said cavity includinga lower surface; and two side ramps distal to a portion of said lowersurface, said side ramps extending upward in a distal direction fromsaid lower surface, and said side ramps being spaced apart from saidaperture and spaced laterally apart from each other.
 2. The unloader ofclaim 1, further comprising: a stop extending upward from said lowersurface; and a center ramp extending upward in the distal direction froma top of said stop, said center ramp positioned laterally between saidside ramps.
 3. The unloader of claim 2, wherein the stop comprises avertical wall extending upward from the lower surface.
 4. The unloaderof claim 2, wherein the side ramps define a trough that extends betweenthe side ramps.
 5. The unloader of claim 4, wherein the stop is locatedat a distal end of the trough.
 6. The unloader of claim 1, wherein theperimeter of the aperture includes two horizontal planes in addition tothe at least two side walls facing each other, the horizontal planesspaced laterally apart on opposite sides of said perimeter.
 7. Theunloader of claim 6, wherein the two horizontal planes define a keyingelement to ensure that the stapler channel is correctly inserted intothe unloader.
 8. The unloader of claim 1, wherein the lower surface ofthe cavity has a concave curvature.
 9. The unloader of claim 8, whereinthe concave curvature of the lower surface is a constant curvature. 10.The unloader of claim 2, wherein the center ramp is planar.
 11. Theunloader of claim 1, wherein the at least two side walls facing eachother comprise a first side wall that is flat and a second side wallthat is rounded.
 12. The unloader of claim 11, wherein the first sidewall has a polygonal shape.
 13. The unloader of claim 1, furthercomprising an upper surface that forms part of a perimeter of thecavity.
 14. The unloader of claim 13, wherein the side ramps extendupward toward the upper surface.
 15. The unloader of claim 13, whereinthe upper surface defines an opening above the side ramps.
 16. Theunloader of claim 15, wherein the opening is sized to allow passage ofthe curved-tip cartridge during unloading of the curved-tip cartridgefrom the stapler channel.
 17. The unloader of claim 2, wherein the twoside ramps comprise top portions that merge with a top edge of thecenter ramp.
 18. An unloader engageable with a stapler channel and acurved-tip cartridge held by the stapler channel, the unloadercomprising: a proximal body; an aperture defined through said proximalbody, said aperture including a perimeter having at least two side wallsfacing each other, the aperture shaped and sized to correspond to anouter surface of the stapler channel and the cartridge held by thestapler channel; a cavity distal to said aperture, said cavity includinga lower surface; and a ramp that is distal to a portion of said lowersurface, said ramp extending upward in a distal direction from saidlower surface, and said ramp being spaced apart from said aperture. 19.The unloader of claim 18, further comprising an upper surface that formspart of a perimeter of the cavity.
 20. The unloader of claim 19, whereinthe ramp extends upward toward the upper surface.